Intralipid 20%

WARNINGS

DEATHS IN PRETERM INFANTS AFTER INFUSION OF INTRAVENOUS FAT EMULSION HAVE BEEN
REPORTED IN THE MEDICAL LITERATURE.2AUTOPSY FINDINGS INCLUDED
INTRAVASCULAR FAT ACCUMULATION IN THE LUNGS. TREATMENT OF PREMATURE AND LOW
BIRTH WEIGHT INFANTS WITH INTRAVENOUS FAT EMULSION MUST BE BASED UPON CAREFUL
BENEFIT-RISK ASSESSMENT. STRICT ADHERENCE TO THE RECOMMENDED TOTAL DAILY DOSE
IS MANDATORY; HOURLY INFUSION RATE SHOULD BE AS SLOW AS POSSIBLE IN EACH CASE
AND SHOULD NOT IN ANY CASE EXCEED 1 G FAT/KG IN FOUR HOURS. PREMATURE AND
SMALL FOR GESTATIONAL AGE INFANTS HAVE POOR CLEARANCE OF INTRAVENOUS FAT EMULSION
AND INCREASED FREE FATTY ACID PLASMA LEVELS FOLLOWING FAT EMULSION INFUSION;
THEREFORE, SERIOUS CONSIDERATION MUST BE GIVEN TO ADMINISTRATION OF LESS THAN
THE MAXIMUM RECOMMENDED DOSES IN THESE PATIENTS IN ORDER TO DECREASE THE LIKELIHOOD
OF INTRAVENOUS FAT OVERLOAD. THE INFANT'S ABILITY TO ELIMINATE THE INFUSED
FAT FROM THE CIRCULATION MUST BE CAREFULLY MONITORED (SUCH AS SERUM TRIGLYCERIDES
AND/OR PLASMA FREE FATTY ACID LEVELS). THE LIPEMIA MUST CLEAR BETWEEN DAILY
INFUSIONS.

CAUTION SHOULD BE EXERCISED IN ADMINISTERING OF INTRALIPID® 20% (20% i.v. fat emulsion) (A 20%
INTRAVENOUS FAT EMULSION) TO PATIENTS WITH SEVERE LIVER DAMAGE, PULMONARY DISEASE,
ANEMIA OR BLOOD COAGULATION DISORDERS, OR WHEN THERE IS DANGER OF FAT EMBOLISM.

WARNING: THIS PRODUCT CONTAINS ALUMINUM THAT MAY BE TOXIC. ALUMINUM
MAY REACH TOXIC LEVELS WITH PROLONGED PARENTERAL ADMINISTRATION IF KIDNEY FUNCTION
IS IMPAIRED. PREMATURE NEONATES ARE PARTICULARLY AT RISK BECAUSE THEIR KIDNEYS
ARE IMMATURE, AND THEY REQUIRE LARGE AMOUNTS OF CALCIUM AND PHOSPHATE SOLUTIONS,
WHICH CONTAIN ALUMINUM.

RESEARCH INDICATES THAT PATIENTS WITH IMPAIRED KIDNEY FUNCTION, INCLUDING PREMATURE
NEONATES, WHO RECEIVE PARENTERAL LEVELS OF ALUMINUM AT GREATER THAN 4 TO 5 MCG/KG/DAY
ACCUMULATE ALUMINUM AT LEVELS ASSOCIATED WITH CENTRAL NERVOUS SYSTEM AND BONE
TOXICITY. TISSUE LOADING MAY OCCUR AT EVEN LOWER RATES OF ADMINISTRATION.

PRECAUTIONS

WHEN INTRALIPID® 20% (20% i.v. fat emulsion) IS ADMINISTERED, THE PATIENTS CAPACITY TO ELIMINATE
THE INFUSED FAT FROM THE CIRCULATION MUST BE MONITORED BY USE OF AN APPROPRIATE
LABORATORY DETERMINATION OF SERUM TRIGLYCERIDES. OVERDOSAGE MUST BE AVOIDED.

DURING LONG TERM INTRAVENOUS NUTRITION WITH INTRALIPID® 20% (20% i.v. fat emulsion) , LIVER FUNCTION
TESTS SHOULD BE PERFORMED. IF THESE TESTS INDICATE THAT LIVER FUNCTION IS IMPAIRED,
THE THERAPY SHOULD BE WITHDRAWN.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Intralipid®
have not been performed to evaluate carcinogenic potential, mutagenic potential,
or effects on fertility.

Pregnancy Category C: Animal reproduction studies have not been conducted
with Intralipid® It is also not known whether Intralipid® can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Intralipid® should be given to a pregnant woman only if clearly
needed.

Nursing Mothers: Caution should be exercised when Intralipid® is
administered to a nursing woman.